Cleared Traditional

K182176 - Polychloroprene Powder Free Sterile Sur...

K182176 is the FDA 510(k) clearance for Polychloroprene Powder Free Sterile Sur... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K182176 · Pt. Medisafe Technologies · General Hospital
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Mar 2019
Decision
230d
Days
Class 1
Risk

K182176 is an FDA 510(k) clearance for the Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use wi.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Tanjung Morawa, Medan, ID). The FDA issued a Cleared decision on March 28, 2019 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pt. Medisafe Technologies devices

Submission Details

510(k) Number K182176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date March 28, 2019
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K182176.
FlexGard Cut-Resistant Glove Liners
K190782 · Ldi Corporation · Jun 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
K190077 · Molnlycke Health Care Us, LLC · May 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
K190018 · Ansell Healthcare Products, LLC · May 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · Ansell Healthcare Products, LLC · Mar 2019
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
K181047 · Smart Glove Corporation Sdn. Bhd. · Jan 2019
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
K180221 · Smart Glove Corporation Sdn. Bhd. · Aug 2018